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A Comparison between Guidelines on Preclinical Safety Evaluation of Medicinal Products of the European Community, the Nordic Countries, and Japan

A Comparison between Guidelines on Preclinical Safety Evaluation of Medicinal Products of the... AROUND THE WORLD A Comparison Between Guidelines on Preclinical Safety Evaluation of Medicinal Products of the European Community, the Nordic Countries, and Japan John P. Griffin ABPI, 12 Whitehall, London SWlA 2DY Introduction In May 1977, the Committee on Proprietary Medicinal Products, which had been established in November 1976 under the terms of European Community (EC) Directive 75/319, set up a working party to produce guidelines on each of the various aspects of the preclinical safety evaluation of medicinal products which would be mutually acceptable to all the countries of the EC (i.e. Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, and the United Kingdom). Since the inception of that working party, guidelines have been issued on: (a) single dose toxicity studies; (b) repeat dose toxicity studies; (c) carcinogenicity studies; (d) reproductive studies, covering fertility, teratology and prenatal and postnatal studies; (e) "mutagenicity studies; (f) pharmacokinetic studies, to be conducted during toxicological evaluation programmes of new medicinal products. The Scandinavian countries (i.e. Denmark, Finland, Iceland, Norway and Sweden) issued guidelines in 1983, which are comparable to the EC guidelines and present a very flexible philosophy similar to that seen in the EC guidelines (1). The EC guidelines were http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Alternatives to Laboratory Animals SAGE

A Comparison between Guidelines on Preclinical Safety Evaluation of Medicinal Products of the European Community, the Nordic Countries, and Japan

Griffin, John P.
Alternatives to Laboratory Animals , Volume 13 (1): 11 – Sep 1, 1985
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References (5)

Publisher
SAGE
Copyright
© 1985 Fund for the Replacement of Animals in Medical Experiments
ISSN
0261-1929
eISSN
2632-3559
DOI
10.1177/026119298501300107
Publisher site
See Article on Publisher Site

Abstract

AROUND THE WORLD A Comparison Between Guidelines on Preclinical Safety Evaluation of Medicinal Products of the European Community, the Nordic Countries, and Japan John P. Griffin ABPI, 12 Whitehall, London SWlA 2DY Introduction In May 1977, the Committee on Proprietary Medicinal Products, which had been established in November 1976 under the terms of European Community (EC) Directive 75/319, set up a working party to produce guidelines on each of the various aspects of the preclinical safety evaluation of medicinal products which would be mutually acceptable to all the countries of the EC (i.e. Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, and the United Kingdom). Since the inception of that working party, guidelines have been issued on: (a) single dose toxicity studies; (b) repeat dose toxicity studies; (c) carcinogenicity studies; (d) reproductive studies, covering fertility, teratology and prenatal and postnatal studies; (e) "mutagenicity studies; (f) pharmacokinetic studies, to be conducted during toxicological evaluation programmes of new medicinal products. The Scandinavian countries (i.e. Denmark, Finland, Iceland, Norway and Sweden) issued guidelines in 1983, which are comparable to the EC guidelines and present a very flexible philosophy similar to that seen in the EC guidelines (1). The EC guidelines were

Journal

Alternatives to Laboratory Animals – SAGE

Published: Sep 1, 1985

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